About US

Quality system

MediNeos is certified ISO 9001:2008 by DNV and submitted to the Italian Drug Agency (AIFA) a self-certification accordingly to the Ministry of Health Decree of November 15th, 2011.

 

MediNeos is also member of EUCROF (European CRO Federation).

MediNeos operates according to Standard Operating Procedures (both with proprietary SOPs and/or SOPs from the customers) in line with the standards for Good Clinical Practice (ICH-GCP).

Every process and stage of any study is regulated by written procedures that are periodically checked and updated in order to ensure the certified quality for the whole project.

In accordance with the FDA Guidance for Industry on 21 CFR Part 11, MediNeos keeps its computerized systems constantly validated.

Furthermore, in order to properly publish data collected from observational research, MediNeos follows the checklists suggested by the STROBE statement, an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in performing and dissemination of observational studies, with the common aim of STrengthening the Reporting of OBservational studies in Epidemiology.

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As a member of ENCePP, MediNeos follows and supports high standards in research methodology, transparency and scientific independence. MediNeos refers to the ENCePP Checklist for Study Protocols complemented by the ENCePP Guide on Methodological Standards in Pharmacoepidemiology.